The comparative gastrointestinal tolerability of proprietary versus generic alendronate in patients treated for primary osteoporosis

Bone ◽  
2012 ◽  
Vol 51 (4) ◽  
pp. 637-642 ◽  
Author(s):  
Erik Landfeldt ◽  
Oskar Ström
2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 209.2-210
Author(s):  
L. Marchenkova ◽  
V. Vasileva ◽  
M. Eryomushkin

Background:Due to the demand for special rehabilitation programs for patients with osteoporotic vertebral fractures (VFs), it is of interest to study the functional abilities of those patients. The scientific hypothesis suggests that osteoporotic VFs would cause muscle weakness, muscle dysfunction and conditional disturbances.Objectives:to estimate muscle strength, motor function and coordination disorders in patients with VFs in the setting of systemic osteoporosis as a basis for rehabilitation programs developing.Methods:120 patients aged 43−80 with primary osteoporosis were enrolled. Study group comprised of 60 subjects (56 women, 4 men) with at least 1 VF confirmed by X-rays. Control group included 60 subjects (56 women, 4 men) with osteoporosis but without any osteoporotic fracture. The examination program included back muscles tenzodynamometry, balance tests and stabilometry.Results:Muscle strength deficiency was estimated in study group in trunk flexors (TF) — 40.9% and in trunk extensors (TE) — 18.1% with an adequate function of the left lateral flexors (LLF) and in right lateral flexors (RLF). Patients with VFs had the lower muscle strength vs controls of TE (15.64±9.8 vs 27.73±9.9 kg, p=0.00002), TF (14.61±8.98 vs 21.28±8.38 kg, p=0.0006), LLF (13.10±7.2 vs 24.06±8.9 kg, p=0.005) and RLF 13.44±7.43 vs 24.26±7.65 kg, p=0.0003). Patients with VFs lose their balance faster during one-leg-standing test with open eyes (5.0 [1.0; 10.0] vs 7.5 [5.0; 10.5] sec in control group, p=0.03) and with closed eyes (2.0 [0; 3.0] vs 3.5 [3.0; 5.0] sec, p=0.04). Fukuda-Unterberger test showed greater side dislocation in study group — 40° [25; 45] vs controls 30° [10; 45], (p=0.02). According to stabilometry study group was characterized vs control group by lower balance coefficient with open eyes (77.2±7.6 vs 85.7±9.4%, p=0.002) and with closed eyes (67.1±9.8 vs 73.4±9.9%, p=0.03), greater sagittal displacement (6.8 [2.1; 37.7] vs 4.8 [1.8; 10.7] mm, p=0.025) and deviation in the saggital plane (1.2 [-1.07; 1.5] vs -1.2 [-1.5; 1.2] mm, p=0.01), and also less pressure center velocity (9.51±4.4 vs 7.1±2.7 mm/sec, р=0.009).Conclusion:Osteoporotic VFs are associated with reduction of trunk muscles strength and negatively affect static and dynamic balance function that should be taken into account when developing rehabilitation programs for these patients.Disclosure of Interests:None declared.


2020 ◽  
Vol 12 ◽  
pp. 1759720X2096926
Author(s):  
Sophia D. Sakka ◽  
Moira S. Cheung

Osteoporosis in children differs from adults in terms of definition, diagnosis, monitoring and treatment options. Primary osteoporosis comprises primarily of osteogenesis imperfecta (OI), but there are significant other causes of bone fragility in children that require treatment. Secondary osteoporosis can be a result of muscle disuse, iatrogenic causes, such as steroids, chronic inflammation, delayed or arrested puberty and thalassaemia major. Investigations involve bone biochemistry, dual-energy X-ray absorptiometry scan for bone densitometry and vertebral fracture assessment, radiographic assessment of the spine and, in some cases, quantitative computed tomography (QCT) or peripheral QCT. It is important that bone mineral density (BMD) results are adjusted based on age, gender and height, in order to reflect size corrections in children. Genetics are being used increasingly for the diagnosis and classification of various cases of primary osteoporosis. Bone turnover markers are used less frequently in children, but can be helpful in monitoring treatment and transiliac bone biopsy can assist in the diagnosis of atypical cases of osteoporosis. The management of children with osteoporosis requires a multidisciplinary team of health professionals with expertise in paediatric bone disease. The prevention and treatment of fragility fractures and improvement of the quality of life of patients are important aims of a specialised service. The drugs used most commonly in children are bisphosphonates, that, with timely treatment, can give good results in improving BMD and reshaping vertebral fractures. The data regarding their effect on reducing long bone fractures are equivocal. Denosumab is being used increasingly for various conditions with mixed results. There are more drugs trialled in adults, but these are not yet licenced for children. Increasing awareness of risk factors for paediatric osteoporosis, screening and referral to a specialist team for appropriate management can lead to early detection and treatment of asymptomatic fractures and prevention of further bone damage.


2014 ◽  
Vol 40 (1) ◽  
Author(s):  
Stefano Stagi ◽  
Loredana Cavalli ◽  
Salvatore Seminara ◽  
Maurizio de Martino ◽  
Maria Luisa Brandi

2007 ◽  
Vol 41 (1) ◽  
pp. 29-34 ◽  
Author(s):  
Hillel Halkin ◽  
Marina Dushenat ◽  
Barbara Silverman ◽  
Varda Shalev ◽  
Ronen Loebstein ◽  
...  

1998 ◽  
Vol 94 (5) ◽  
pp. 549-555 ◽  
Author(s):  
Richard O. C. Oreffo ◽  
Stéphanie Bord ◽  
James T. Triffitt

1. Stem and progenitor cells present within bone marrow give rise to colony forming units-fibroblastic (CFU-F) which can differentiate into fibroblastic, osteogenic, myogenic, adipogenic and reticular cells. The decrease in skeletal bone formation and rate of fracture repair observed with ageing and in osteoporosis has been suggested to be due to a decrease in numbers of these progenitors, but human studies are limited. 2. We have tested the potential to form CFU-F in a total of 99 patients undergoing corrective surgery (16 controls, 14–48 years of age) or hip arthroplasty for osteoarthritis (57 patients, 28–87 years of age) or osteoporosis (26 patients, 69–97 years of age). Total colony number, alkaline phosphatase-positive colony number and colony size were determined. 3. No decrease in colony forming efficiency under the culture conditions used was observed in all populations examined irrespective of age, disease or gender, as determined by the lack of correlation between colony formation and age. 3. Examination of colony sizes showed a significant reduction in colony size with age in osteoarthritis and in control populations indicating a change in cellular proliferative potential with age. 4. Examination of number and percentage of alkaline phosphatase-positive CFU-F showed a significant decrease in osteoporotic patients compared with controls and osteoarthritis patients, indicating altered differentiation potential. 5. These results suggest that the reduction in bone mass with ageing may be due to reduction of the proliferative capacity of progenitor cells or their responsiveness to biological factors leading to alteration in subsequent differentiation. The maintenance of CFU-F number and alkaline phosphatase activity in these osteoarthritis patients may, in part, explain the inverse relationship observed for the preservation of bone mass between generalized osteoarthritis and primary osteoporosis.


Nutrients ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 2066
Author(s):  
Oliver Chen ◽  
Traci M. Blonquist ◽  
Eunice Mah ◽  
Kristen Sanoshy ◽  
Dawn Beckman ◽  
...  

Nutritional ketosis is a state of mildly elevated blood ketone concentrations resulting from dietary changes (e.g., fasting or reduced carbohydrate intake) or exogenous ketone consumption. In this study, we determined the tolerability and safety of a novel exogenous ketone diester, bis-hexanoyl-(R)-1,3-butanediol (BH-BD), in a 28-day, randomized, double-blind, placebo-controlled, parallel trial (NCT04707989). Healthy adults (n = 59, mean (SD), age: 42.8 (13.4) y, body mass index: 27.8 (3.9) kg/m2) were randomized to consume a beverage containing 12.5 g (Days 0–7) and 25 g (Days 7–28) of BH-BD or a taste-matched placebo daily with breakfast. Tolerability, stimulation, and sedation were assessed daily by standardized questionnaires, and blood and urine samples were collected at Days 0, 7, 14, and 28 for safety assessment. There were no differences in at-home composite systemic and gastrointestinal tolerability scores between BH-BD and placebo at any time in the study, or in acute tolerability measured 1-h post-consumption in-clinic. Weekly at-home composite tolerability scores did not change when BH-BD servings were doubled. At-home scores for stimulation and sedation did not differ between groups. BH-BD significantly increased blood ketone concentrations 1-h post-consumption. No clinically meaningful changes in safety measures including vital signs and clinical laboratory measurements were detected within or between groups. These results support the overall tolerability and safety of consumption of up to 25 g/day BH-BD.


Author(s):  
Aashima Dabas ◽  
Rakhi Malhotra ◽  
Ravindra Kumar ◽  
Rajesh Khadgawat

Abstract Objectives Childhood osteoporosis is an uncommon condition that usually develops secondary to underlying disease states. Idiopathic juvenile osteoporosis or early onset osteoporosis is a rare cause of primary osteoporosis in childhood associated with mutations in “bone fragility” genes. Case presentation The index case presented with upper back pain and was detected to have multiple vertebral fractures. Further workup for the cause revealed a homozygous benign mutation in low-density lipoprotein receptor-related protein 5, which was also detected in the mother who remained asymptomatic till presentation. The child was successfully treated with intravenous zoledronate. Conclusions The case report describes the management approach and four-year follow-up of the child.


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